Pursuant to section 20 of the Medicines Act 1981, the Minister of Health hereby consents to the distribution in New Zealand of the new medicines set out in the Schedule hereto:
Schedule
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Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturer:
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Clindamycin Mylan
Clindamycin phosphate 197.88mg/mL equivalent to clindamycin 150mg/mL
Solution for injection
Mylan New Zealand Limited
Mylan Teoranta, Kilroe East, Galway, Ireland
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Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturers:
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Paracetamol Kabi
Paracetamol 10mg/mL
Solution for injection
Fresenius Kabi New Zealand Limited
Fresenius Kabi Austria GmbH, Graz, Austria
Fresenius Kabi France, Louviers, France
Fresenius Kabi Norge AS, Halden, Norway
Fresenius Kabi Deutschland GmbH, Friedberg, Germany
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Product:
Active Ingredients:
Dosage Form:
New Zealand Sponsor:
Manufacturer:
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Simbrinza
Brimonidine tartrate 2mg/mL
Brinzolamide 10mg/mL
Eye drops, suspension
Alcon Laboratories
SA Alcon Couvreur NV, Puurs, Belgium
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Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturer:
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Tranexamic-AFT
Tranexamic acid 100mg/mL
Solution for injection
AFT Pharmaceuticals Limited
Labiana Pharmaceuticals SL, Barcelona, Spain
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Dated this 30th day of June 2016.
CHRIS JAMES, Acting Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).
Gazette.govt.nz